NCT02398942

Brief Summary

Aim: The aim of this study is to analyze the clinical and radiological outcomes of patients with a proximal pole fracture of the scaphoid Primary null hypothesis: There are no factors associated with nonunion of a proximal pole fracture of the scaphoid. Secondary null hypothesis: Patients with an acute proximal pole fracture of the scaphoid have QuickDASH (Disabilities of the Arm, Shoulder, and Hand) scores at or above the population norm (a score of 13 in the Norway and 10.9 in the United States), 2 to 6 months after injury.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

10 months

First QC Date

March 4, 2015

Last Update Submit

December 20, 2016

Conditions

Proximal Pole Fractures of the Scaphoid

Outcome Measures

Primary Outcomes (2)

  • Disability measured using QuickDASH

    6 months

  • Nonunion of Fracture

    The nonunion of the fracture will be measured using CT imaging

    6 months

Study Arms (1)

Proximal Pole Fracture of the Scaphoid

QuickDASH 6 months after injury CT scan 6 months after injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with proximal pole fracture of the scaphoid

You may qualify if:

  • Age 18 years or greater
  • Proximal pole fracture of the scaphoid on computed tomography scans made in the planes defined by the long axis of the scaphoid. The proximal pole will be defined as the proximal fifth of the scaphoid, excluding small scapholunate ligament avulsion fractures.
  • Interval between injury and diagnosis of less than 2 weeks.
  • English or Spanish fluency and literacy

You may not qualify if:

  • Pregnant women
  • Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
  • Patients with other fractures or injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • David Ring, MD PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Orthopaedic Hand and Upper Extremity Service

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 26, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 22, 2016

Record last verified: 2016-12